European Commission's Breakthrough Device Pathway for MedTech | MedTech Leading Voice posted on the topic | LinkedIn
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What is the FDA Breakthrough Device Designation?
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We're pleased to share our Elecsys Neurofilament Light Chain (NfL) test has been granted FDA Breakthrough Device Designation, and has the potential to help laboratories broadly scale multiple sclerosis testing. https://bit.ly/3squUc4 | Roche Diagnostics USA
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FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System
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